This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 20 mg tablet) in healthy adult subjects under fasting conditions.

Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table.

Screening procedures: Each subject will complete the screening process within 28 days prior to dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.

Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.

Subjects demonstrating a positive drug abuse screen when screened for this study.

Female subjects who are currently breastfeeding.

Female subjects demonstrating a positive pregnancy screen.

Subjects with a history of allergic response(s) to leflunomide or related drugs.

Subjects with a history of clinically significant allergies including drug allergies.

Subjects with a clinically significant illness during the 4 weeks prior to dosing (as determined by the clinical investigators).

Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.

Subjects who report donating greater than 150 mL of blood within 30 days prior to dosing. All subjects will be advised not to donate blood for four weeks after completing the study.

Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.

Subjects who report receiving any investigational drug within 30 days prior to dosing.

Subjects who report taking any prescription medication in the 14 days prior to dosing, with the exception of postmenopausal women on HRT may continue their HRT and topical products without systemic absorption.

Subjects who report an intolerance of direct venipuncture.

Subjects who report consuming an abnormal diet during the 28 days prior to dosing.

Subjects who report taking any product containing leflunomide within 180 days of dosing.

Subjects who report taking any herbal products within 7 days prior to dosing.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834418